Ventana recalls ultraView SISH DNP Detection Kit due to leaking and sticking reagent dispensers, which may cause inaccurate test results in medical diagnostics.
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Ventana is recalling its ultraView SISH DNP Detection Kit because reagent dispensers can leak or stick, potentially causing inaccurate test results. This affects medical labs using the kit for diagnostic testing.
The reagent dispensers in the kit can leak or stick, leading to inaccurate test results. This could affect the reliability of diagnostic tests for conditions like cancer and infections.
Medical labs using the ultraView SISH DNP Detection Kit for diagnostic testing are most affected. Patients receiving tests with this kit may have inaccurate results.
Check for Ventana Part Number 760-098 or Roche GMMI 05572037001 on the kit. The kit was sold with UDI 04015630970384 and Lot Number Y15146.
Look for Ventana Part Number 760-098 or Roche GMMI 05572037001 on the kit label.
The recall is due to increased reports of leaking and sticking reagent dispensers, which could cause inaccurate test results.
The official recall notice does not specify a remedy, so check with Ventana for further instructions.
The recall indicates a potential risk of inaccurate test results, but the kit is not considered dangerous for immediate harm.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0733-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0733-2018 from Ventana. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
